Our findings indicate that men facilitated contraceptive use for their partners. Although the IMB model does not fully explain our findings, our results show that the intervention's content and its training in communication skills are essential mechanisms for successfully enabling men to help couples use a contraceptive.

BackgroundIn VOICE, a multisite HIV pre-exposure prophylaxis (PrEP) trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF), we explored socio-cultural and contextual factors that influenced participants’ experience of daily vaginal gel and oral tablet regimens in VOICE.MethodsIn Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41), serial ethnographic interviews (n = 21), or focus group discussions (n = 40). Audiotaped interviews were transcribed, translated, and coded thematically for analysis.ResultsOf the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support–from partners and significant others–and the relationship tradeoffs entailed by using the products appear to discourage adequate product use.ConclusionsPersonal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that shaped women’s perceptions of trial participation and experiences with investigational products. Whether these impacted women’s behaviors and may have contributed to ineffective trial results warrants further investigation.

Research suggests that spousal communication and male involvement in decision making can positively influence family-planning use and continuation. However, few existing studies explore the dynamics of this communication and how they factor into family-planning decision making. Building upon a recent evaluation of a theory-based male-involvement intervention in Malawi, this study aimed to fill this gap by examining the role of communication in the intervention's success, through semi-structured in-depth interviews with male participants and female partners of study participants. Results support the idea that communication is an integral component of successful interventions to increase male involvement in family planning. Participants reported improvements in spousal communication, increased frequency of communication, and an increase in shared decision making as a result of the study, which directly contributed to their family-planning use. This effect was often mediated through increased knowledge or reduced male opposition to family planning. Further analysis of communication and decision-making dynamics revealed shifts in gendered communication norms, leading to improvements in spousal relationships in addition to contraceptive uptake. This study shows that interventions can and should encourage spousal communication and shared decision making, and it provides an effective model for involving men in family-planning use.

Objectives In VOICE, a phase IIB trial of daily oral and vaginal tenofovir for HIV prevention, ≥50% of women receiving active products had undetectable tenofovir in all plasma samples tested. MTN-003D, an ancillary study using in-depth interviews (IDIs) and focus group discussions (FGDs), together with retrospective disclosure of plasma tenofovir pharmacokinetic (PK) results, explored adherence challenges during VOICE. Methods We systematically recruited participants with PK data (median 6 plasma samples), categorized as low (0%, N=79), inconsistent (1%-74%, N=28), or high (≥75%; N=20) based on frequency of tenofovir detection. Following disclosure of PK results, reactions were captured and adherence challenges systematically elicited; IDIs and FGDs were audio-recorded, transcribed, coded, and thematically analyzed. Results We interviewed 127 participants from South Africa, Uganda, and Zimbabwe. The most common reactions to PK results included surprise (41%; low PK), acceptance (39%; inconsistent PK), and happiness (65%; high PK). Based on participants’ explanations, we developed a typology of adherence patterns: noninitiation, discontinuation, misimplementation (resulting from visit-driven use, variable taking, modified dosing or regimen), and adherence. Fear of product side effects/harm was a frequent concern, fueled by stories shared among participants. Although women with high PK levels reported similar concerns, several described strategies to overcome challenges. Women at all PK levels suggested real-time drug monitoring and feedback to improve adherence and reporting. Conclusions Retrospective provision of PK results seemingly promoted candid discussions around nonadherence and study participation. The effect of real-time drug monitoring and feedback on adherence and accuracy of reporting should be evaluated in trials.